Drug Product Process Expert
Vor 3 Tagen
Direct message the job poster from Haybury
Process Engineering Lead – External Manufacturing (Aseptic Drug Product)
We are partnering with a global biopharmaceutical organization focused on delivering high-quality, life-saving treatments through cutting-edge manufacturing and process innovation. With a strong commitment to excellence in external manufacturing, this company is expanding its team and seeking an experienced Process Engineering Lead to support and optimise drug product manufacturing operations at CMO Partners.
This role will be pivotal in ensuring robust, high-performance production processes, driving continuous improvement initiatives, and supporting investigations related to process robustness. It offers the opportunity to work on a diverse portfolio of sterile drug products while collaborating with international teams.
Location: Europe (Significant international travel required – up to 40%)
Key Responsibilities:
- Lead the transition of technical oversight from technology transfer to routine manufacturing at external partners
- Establish key process performance indicators and monitor trends to enhance operational efficiency
- Support investigations into deviations related to process robustness and implement corrective/preventative actions (CAPAs)
- Identify and implement improvements to drive yield and performance enhancements at CMOs
- Collaborate cross-functionally with internal and external teams, acting as a key technical interface in external manufacturing operations
- Provide on-site technical support for CMO operations and ensure alignment with quality and regulatory requirements
Ideal Candidate Profile:
- Advanced degree (Master's or PhD preferred) in Engineering, Biotechnology, or a related scientific field
- 9+ years of experience in aseptic/sterile pharmaceutical manufacturing, process engineering, or MSAT
- Expertise in isolator technology, single-use systems, filtration setup (including PUPSIT), and visual inspection (manual, semi-automated, and automated)
- Deep understanding of Annex 1 and sterility assurance principles within an operations or engineering setting
- Strong problem-solving skills with experience in GMP, process monitoring, and data analysis
- Fluency in German and English is required
Why Join?
This is a fantastic opportunity to work at the cutting edge of pharmaceutical manufacturing, leading critical process improvements that impact global drug supply. You will play a key role in ensuring the successful manufacturing of essential medicines while working in a dynamic, collaborative environment.
If you have a passion for technical leadership and want to drive operational excellence in sterile drug product manufacturing, we'd love to hear from you
Seniority levelMid-Senior level
Employment typeFull-time
Job functionEngineering, Manufacturing, and Production
IndustriesBiotechnology Research, Pharmaceutical Manufacturing, and Research Services
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